Idorsia Pharmaceuticals Ltd : Idorsia announces the publication of positive data with daridorexant in patients with chronic insomnia and nocturia

Phase 4 Study Design and Objectives

The Phase 4 study, titled Efficacy and Safety of Daridorexant in Patients with Insomnia and Nocturia, aimed to evaluate the efficacy and safety of daridorexant in patients with insomnia and nocturia. The study was conducted in a randomized, double-blind, placebo-controlled manner, with a total of 240 patients enrolled.

Chronic insomnia is defined as difficulty initiating and/or maintaining sleep at least three times a week for a minimum of three months. Nocturia is waking during the night due to the need to urinate. Insomnia and nocturia frequently co-exist, particularly in older patients.

The sleep quality improved as the number of nocturnal awakenings increased. Nocturnal awakenings were higher among patients with comorbid insomnia and nocturia compared to those with insomnia alone.

Efficacy of Daridorexant in Improving Sleep Quality

Daridorexant, a selective orexin receptor antagonist, has been shown to have a positive impact on sleep quality in patients with insomnia. The medication works by blocking the action of orexins, which are neurotransmitters that regulate arousal and wakefulness. • Orexins are produced in the hypothalamus and play a crucial role in the body’s natural sleep-wake cycle. • When orexins bind to their receptors, they stimulate the brain’s wakefulness centers, making it difficult to fall asleep and stay asleep.

The study found that daridorexant was effective in reducing symptoms of insomnia and improving sleep quality in patients with chronic insomnia and comorbid nocturia.

Daridorexant was effective in reducing symptoms of insomnia and improving sleep quality in patients with chronic insomnia and comorbid nocturia.

The study found that daridorexant was safe and well tolerated in patients with chronic insomnia and comorbid nocturia.

No serious adverse events (AEs) or AEs leading to discontinuation were reported in the study.Mechanism of Action

Daridorexant is a selective orexin receptor antagonist that targets the orexin system, which plays a crucial role in regulating sleep-wake cycles.

The effects of daridorexant on nocturia are also noteworthy, as it reduces the frequency of nighttime awakenings and improves the quality of sleep.

Mechanism of Action

Daridorexant is a novel orexin receptor antagonist that targets the orexin system, which plays a crucial role in regulating sleep-wake cycles. Orexins are neuropeptides that stimulate the release of various neurotransmitters, including histamine, serotonin, and acetylcholine, which in turn promote wakefulness and arousal. By blocking the orexin receptors, daridorexant reduces the activity of these neurotransmitters, leading to a decrease in wakefulness and an increase in sleepiness.

6-10% of adults living with chronic insomnia are not recognized.

Difficulty falling asleep or staying asleep

Waking up frequently during the night

Feeling tired or groggy upon waking

Difficulty concentrating and making decisions

Increased risk of chronic diseases such as diabetes, high blood pressure, and cardiovascular disease

The Consequences of Untreated Sleep Disorders

Untreated sleep disorders can have severe consequences on overall health and well-being.

Idorsia is a global leader in the development of innovative treatments for sleep disorders.

World Sleep Day 2025 is an annual event that aims to raise awareness about the importance of sleep health.

The event is organized by the World Sleep Society (WSS) and is supported by various sleep-related organizations and companies, including Idorsia.

The main goal of World Sleep Day 2025 is to promote sleep health and reduce the stigma associated with sleep disorders.The Importance of Sleep Health

Sleep is a vital aspect of our overall health and well-being. It plays a crucial role in physical and mental restoration, and its importance cannot be overstated. During sleep, our bodies repair and regenerate tissues, build bone and muscle, and strengthen our immune systems.

Availability and Approval

Daridorexant is commercially available in several countries, including the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, France, Sweden, and Japan.Mechanism of Action

Daridorexant is a selective orexin receptor antagonist, which means it blocks the action of orexins, two proteins that regulate sleep and wakefulness.

The study was conducted over a period of 12 weeks, with 30 participants recruited from the general population.

Primary complaint of insomnia

No history of sleep disorders or other psychiatric conditions

No current or past use of sedatives or hypnotics

No history of substance abuse or dependence

Ability to provide informed consent

Treatment and Placebo

The treatment group received daridorexant 50 mg daily, while the placebo group received a matching placebo.

Significant negative impact on daytime functioning refers to excessive daytime sleepiness (EDS) that is severe enough to interfere with one’s ability to function normally in daily life. The criteria for diagnosing insomnia are established by the International Classification of Sleep Disorders (ICSD-2) and have been endorsed by the American Academy of Sleep Medicine (AASM). The diagnostic criteria are: (1) the sleep disturbances must be present on at least three consecutive nights; (2) the sleep disturbances must be associated with excessive daytime sleepiness; and (3) the sleep disturbances must be present in the presence of adequate sleep opportunities. The presence of other conditions, such as sleep apnea or restless leg syndrome, does not affect the diagnosis of insomnia. The ICSD-2 criteria are used to diagnose insomnia in clinical settings. The AASM endorses the ICSD-2 criteria and recommends that the diagnosis of insomnia be made by a healthcare professional. The diagnosis of insomnia is not based on self-reported sleep questionnaires or sleep diaries. The diagnosis of insomnia is based on a comprehensive clinical evaluation, including a review of the patient’s medical history, a physical examination, and a sleep study (if necessary). A comprehensive clinical evaluation is necessary to rule out other sleep disorders and to ensure that the insomnia is not a symptom of an underlying medical condition.

Managing Insomnia: A Comprehensive Approach

Understanding Insomnia

Insomnia is a complex condition characterized by difficulty initiating or maintaining sleep, or both. It can be acute or chronic, and its causes can be varied, including stress, anxiety, and lifestyle factors.

Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or both.

(DSM-5) criteria for nocturia.

Understanding Nocturia

Nocturia is a common condition characterized by the need to wake up at least twice during the night to void. It is estimated that approximately 40% of adults experience nocturia, with the prevalence increasing with age. • The condition can be caused by various factors, including:

Medical conditions such as diabetes, sleep apnea, and urinary tract infections

Medications that increase urine production or suppress the kidneys’ ability to concentrate urine

Lifestyle factors such as fluid intake, diet, and physical activity

Impact on Sleep Quality

Nocturia can significantly disrupt sleep quality, leading to:

Reduced sleep duration

Increased sleep fragmentation

Decreased sleep efficiency

Increased risk of sleep disorders such as insomnia and sleep apnea

Diagnostic Criteria

The Diagnostic and Statistical Manual of Mental Disorders 5th ed. (DSM-5) provides criteria for diagnosing nocturia.

Idorsia is a Swiss-based company that has been in the pharmaceutical industry for over 50 years, with a strong focus on neuroscience and pain management.

Neuroscience: Idorsia is committed to advancing the understanding of the brain and nervous system, with a focus on developing treatments for neurological disorders such as Parkinson’s disease, multiple sclerosis, and epilepsy.

Pain Management: The company is dedicated to improving pain management, with a focus on developing innovative treatments for chronic pain and other pain-related disorders.

Psychiatry: Idorsia is also focused on developing treatments for psychiatric disorders, including depression, anxiety, and schizophrenia.The Approach to Innovation

Idorsia’s approach to innovation is centered around the development of transformative medicines that address the unmet medical needs of patients.

Idorsia is a Swiss pharmaceutical company that has been in operation since 2000.

Further details on this topic will be provided shortly.